Phantom-limb pain is a typical ramification of amputation in as much as 80% of individuals who undergo the surgical procedure and is a central pain phenomenon due to remodeling of the CNS . This chronic pain syndrome and its incidence are climbing due to injuries from the Iraq and Afghanistan military conflicts. Until recently, the predominant theory for the cause of phantom limbs was irritation in the severed nerve endings . When a limb is amputated, many severed nerve endings are terminated at the remaining stump. These nerve endings can become inflamed, and were thought to send anomalous signals to the brain. These signals, being functionally nonsense, were thought to be interpreted by the brain as pain. Melzac proposed that a pain neuromatrix exists that is activated in specific brain regions that ultimately result in pain sensations independent of the sensory source of the pain . Continued research now indicates that the pathophysiology comes from changes at the dorsal horn and higher levels in the CNS.
Prophylactic measures exist for elective amputations (as in diabetic patients with chronic wounds, osteomyelitis, etc.). Traumatic amputations do not permit prophylactic care; moreover, to date, there has been no effective reproducible treatment.
This case report illustrates the use of a promising and relatively new electromedical treatment for phantom limb pain. The device uses non-invasive alternating current, delivered by a sophisticated wave generator, and administered transcutaneously. The complex signal energy waveforms are formed first as a simple biphasic symmetrical sinusoidal wave, and then modulated by frequency (cycles/sec, or hertz, Hz) and dosage (amplitude) to create complex rapidly changing signals that easily pass through the dermal tissue and avoid repetitive nerve accommodation. These specific and time-varying electric signal currents are introduced through the skin by special vasopneumatic electrodes into the local injured or diseased area. The administration of these complex electrical signals is accomplished by advanced electromedical signal energy microprocessors not even available just 10 years ago. The term that is used to describe these electric currents is electric signaling, and when applied to a patient it is referred to as Electric Signal Treatment (EST). The EST device, an ultra-high digital frequency generator (UHdfg), can deliver the targeted and patented frequency-modulated (FM) and amplitude modulated (AM) electric current (signals) transcutaneously into the body. The detail regarding EST technology was first introduced, defined and described in earlier published work .
These technologically-advanced electric time-varying signals and associated harmonics offer numerous physiological advantages over older-type electromedical devices, such as TENS or Interferential Current Therapy. Numerous benefits include a profound anti-inflammatory effect, increasing blood flow, increasing cyclic AMP (cAMP) levels and utilization for cell healing, and more. EST allows a much greater depth of penetration through the dermal tissue and into deeper tissues by the application of higher frequency electric signals which lower skin impedance. The ever changing nature of these signals makes it much more difficult for the peripheral and central nervous system to accommodate (find ways to defeat the effects of the signals). This unique multiplex signaling configuration allows for optimum voltage application which affects voltage-gated channels and receptors within targeted biological tissue .
Case report:
PC is a 73 year old Hispanic male who is a bilateral amputee secondary to advanced peripheral vascular disease and diabetes of 30 years. He underwent a right AKA in 2006 & left BKA in 2008. He has had phantom limb pain for a number of years which was controlled with Lortab 10/500mg, 4 per day, and Tramadol 50mg 3 per day. There were no aggravating factors for the episodes of his phantom limb pain. The pain was equal in both the left and right side with the toes and heels being the primary site of the pain. The episodes of pain would be described as pins and needles, constant and graded as a 9-10/10 in severity.
For approximately one month prior to his visit to our clinic, PC had not been able to control the phantom pain with the above medications. In the 3 days prior to coming to the clinic he had been to local hospitals three times for pain control, where he was given injections of morphine. In the 72 hours prior to his visit the pain had been constant and severe; only after the third visit to the ER, and receiving morphine for the third time did he get some measurable relief.
During the first visit to our clinic he was lethargic, nauseated and actually vomited in the examination room during his visit. His blood sugar was 107 and his diabetes was under fair control by taking Humulin 70/30 on a sliding scale basis and with his HgB A1C at 7.8 PC also had Stage 3 Renal Failure and had stents placed secondary to a heart attack 3 years prior.
When PC presented to the clinic, treatment was initiated daily for the first week and then every other day with specific-parameter electric cell signal treatment (EST). Initial digital UHdfg programs parameters were selected to provide anti-inflammatory and nerve blocking effects. Four venturi-type vacuum electrodes were utilized on each limb through four independent circuit channels of a Sanexas neoGEN electric cell signaling device with treatment sessions each averaging twenty minutes. On the first day alone, the patient stated pain relief from a 9-10/10 to a 5/10 on the NRS.
Subsequent digital programs were continually advanced to include signals that addressed and treated varying stages of inflammation, pain, edema, circulation and neural deficits. From late May 2013 to early July 2013 he received twenty (20) EST treatments with the phantom limb pain resolving over a 6 week period.
In July 2013 he suffered several exacerbations when he started to have pain at phantom sites proximal to the distal feet (e.g. in the right lateral ankle, but not the right great toe again and not on the left side). PC was taken to the ER again for morphine shots, which were given to the point where he started vomiting. Subsequently, he was seen at intervals of approximately once - twice a week for the next four months for maintenance; any painful exacerbations became confined to the stumps only. PC has elected to continue to be managed with periodic EST-only treatment visits to the clinic on a PRN basis. His treatment visit frequency continues to reduce and his last visit to the clinic was 3 months prior to the date of this report.
Discussion:
This case report illustrates the potential for sophisticated and complex electric current applications (signaling) to treat pain of central origin. The patient has experienced the elimination of the phantom limb pain over time. There is evidence in this case report that the central pain was modified when he presented with central pain only at more proximal aspect, namely the stumps after EST treatment. With ongoing EST treatment, the patient progressed to manifestations of only limited intermittent stump pain. His current exacerbations are confined solely to occasional stump pain, and with periodic maintenance treatment, he has been relatively easy to manage.
The authors are not aware of any truly effective treatments for central pain other than pharmacological. The advantages of essentially risk-free electric cell signaling are clear over using centrally acting drugs: reduced costs and reduced side effects. The question of reproducible and comparative efficacy will need to be determined in future studies.
EST shows promise for not only the treatment of diabetic and other peripheral vascular induced limb amputations, but for efficacious treatment of our returning soldiers as well. These multiplexed and continually varied electric signals have a direct effect on voltage-dependent gates, and the alteration in the membrane physiology is objectively measureable . A number of scientific citations demonstrate both conformational changes in the G-proteins of the cell membrane and subsequent second-messenger (cAMP) formation directing cell-specific activity, including regeneration and repair .
The electric signaling treatment is noninvasive, safe and cost effective. Although the EST device required is far more advanced than typical TENS devices or other traditional electrotherapy devices that are currently available, its cost is still such that medical clinics nationwide could treat patients in a cost effective manner. We envision future directions of research and clinical use to include the synergistic incorporation of electric cell signaling technology with recent developments in quantum physics as they pertain to biological oscillations, neural networks, cellular microtubule function in energy transfer and to improve proton motive force and cellular capacity .